CN114534004A - Medical device for anti-bubble drug delivery - Google Patents

Abstract

The invention relates to a hydrophilic infusion tube and a hydrophilic infusion part. A fluid path connects the first fluid port and the second fluid port, the fluid path being formed by a substrate suitable for fluid infusion and a hydrophilic fluid interface surface disposed on an interior surface of the fluid path. The hydrophilic fluid interface surface provides a water wetting contact angle that is less than the water wetting contact angle provided by the substrate. The invention also relates to an infusion set.

Description

Medical device for anti-bubble drug delivery

Cross Reference to Related Applications

The present application claims benefit of U.S. patent application No.17/103,459 entitled "MEDICAL DEVICES FOR ANTI-BUBBLE medicine DELIVERY" filed 24/11/2020, the disclosure of which is incorporated herein by reference in its entirety FOR all purposes.

Background

Infusion of drugs is typically accomplished by infusion pump systems or gravity feed systems and corresponding Intravenous (IV) sets. A typical iv set has infusion components such as a drip chamber, check valves, roller clamps, filters, and tubing couplers, all of which are connected together by primary and secondary iv tubing. Prior to attaching the iv tubing to the patient, the infusion component and tubing must be primed by placing iv fluid in the infusion component and iv tubing to remove all air. Intravenous tubing is primed to prevent air from entering the circulatory system, thereby preventing air embolism, a potential complication of intravenous therapy. The air embolus can enter the patient's blood system through cut or unprimed intravenous tubing, an infusion member access port, and a low fluid infusion member. Air embolism can be fatal, and death occurs as long as 10ml of air is available. Known solutions for minimizing or preventing the occurrence of air bubbles include the use of adapters, sensors and membrane technologies to capture air bubbles to minimize bubbles and accelerate perfusion. However, these solutions require additional devices, which increase the complexity of the iv set, while resulting in the need to train the user to properly use the air bubble removal device.

It would be desirable to provide infusion components and intravenous tubing with hydrophilic materials to prevent air bubbles from adhering to fluid path surfaces, thereby reducing the occurrence of air emboli, reducing priming time, eliminating the need for additional training, and improving manufacturing costs by eliminating the need for additional devices.

Disclosure of Invention

The present disclosure provides medical tubing and infusion components having a hydrophilic coating and/or a hydrophilic hybrid substrate that reduces the water wetting angle such that air bubbles slide off or break away (pop off) and disappear quickly upon contacting a hydrophilic surface, thereby reducing the time required for priming and the risk of air embolism caused by fluid transport of the intravenous set.

In one or more embodiments, a hydrophilic infusion tube is provided. The hydrophilic infusion tube comprises a flexible tube configured to connect the first fluid port and the second fluid port, the flexible tube comprising a substrate suitable for fluid infusion and a hydrophilic fluid interface surface disposed on an inner surface of the flexible tube, wherein the hydrophilic fluid interface surface provides a water wetting contact angle that is less than a water wetting contact angle provided by the substrate.

In one or more aspects, the substrate comprises one or more of Thermoplastic Polyurethane (TPU), thermoplastic elastomer (TPE), Thermoplastic Polyolefin (TPO), soft polyvinyl chloride (PVC), silicone, thermoplastic vulcanizate (TPV) (ethylene propylene diene monomer (EPDM) + polypropylene (PP)), thermoplastic styrene elastomer (TPS) (styrene-butadiene-styrene (SBS)/styrene-ethylene-butylene-styrene (SEBS)/styrene-isoprene-rubber (SIS)/styrene-ethylene-propylene-styrene (SEPS)) and mixtures thereof with polyolefins, and thermoplastic polyester elastomer (TPEE) (polyether ester) rubber. In one or more aspects, the hydrophilic fluid interface surface comprises a hydrophilic material coated on a substrate. In one or more aspects, the hydrophilic material comprises a guanidinium copolymer. In one or more aspects, the hydrophilic material provides a lower coefficient of friction than the coefficient of friction provided by the base material. In one or more aspects, the hydrophilic material provides a higher material wettability than the material wettability provided by the substrate.

In one or more aspects, the hydrophilic fluid interface surface comprises a hydrophilic material grafted onto a substrate. In one or more aspects, the hydrophilic fluid interface surface comprises a mixture of a substrate and a hydrophilic additive. In one or more aspects, the hydrophilic additive comprises one or more of polyvinylpyrrolidone (PVP), polyvinyl alcohol, Chitosan (CS), polyamides, polyethylene oxide (PEO), polyethylene glycol (PEG), and polyetheramines. In one or more aspects, the hydrophilic additive comprises a guanidinium copolymer. In one or more aspects, the hydrophilic additive comprises up to 10% by weight of the combination of the substrate and the hydrophilic additive. In one or more aspects, the hydrophilic additive comprises up to 20% by weight of the combination of the substrate and the hydrophilic additive.

In one or more embodiments, a hydrophilic infusion component is provided. The hydrophilic infusion component includes a housing. The housing includes a first fluid port, a second fluid port, a substrate adapted for fluid infusion, and a fluid path disposed between the first fluid port and the second fluid port. A hydrophilic fluid interface surface is disposed on an inner surface of the fluid path. The hydrophilic fluid interface surface provides a smaller water wetting contact angle than the substrate provides.

In one or more aspects, the substrate comprises one or more of Thermoplastic Polyurethane (TPU), thermoplastic elastomer (TPE), Thermoplastic Polyolefin (TPO), soft polyvinyl chloride (PVC), silicone, thermoplastic vulcanizate (TPV) (ethylene propylene diene monomer (EPDM) + polypropylene (PP)), thermoplastic styrene elastomer (TPS) (styrene-butadiene-styrene (SBS)/styrene-ethylene-butylene-styrene (SEBS)/styrene-isoprene-rubber (SIS)/styrene-ethylene-propylene-styrene (SEPS)) and mixtures thereof with polyolefins, and thermoplastic polyester elastomer (TPEE) (polyether ester) rubber. In one or more aspects, the hydrophilic fluid interface surface comprises a hydrophilic material coated on a substrate. In one or more aspects, the hydrophilic fluid interface surface comprises a hydrophilic material grafted onto a substrate. In one or more aspects, the hydrophilic fluid interface surface comprises a mixture of a substrate and a hydrophilic additive. In one or more aspects, the hydrophilic additive includes one or more of polyvinylpyrrolidone (PVP), polyvinyl alcohol, Chitosan (CS), polyamides, polyethylene oxide (PEO), polyethylene glycol (PEG), polyetheramines, and guanidine salt copolymers.

In one or more embodiments, an infusion set is provided. The infusion set includes an infusion component and a hydrophilic infusion tube. The hydrophilic infusion tube comprises a flexible tube configured to connect the fluid port of the infusion component to a different fluid port, the flexible tube comprising a substrate suitable for fluid infusion. The hydrophilic infusion tube further comprises a hydrophilic fluid interface surface disposed on the inner surface of the flexible tube. The hydrophilic fluid interface surface provides a smaller water wetting contact angle than the substrate provides. The flexible tube is configured to provide a fluid channel free of air bubble accumulation on an inner surface of the flexible tube.

In one or more aspects, the infusion component is a hydrophilic infusion component comprising a housing comprising a first fluid port, a second fluid port, a substrate adapted for fluid infusion, and a fluid pathway disposed between the first fluid port and the second fluid port, wherein a hydrophilic fluid interface surface is disposed on an inner surface of the fluid pathway, and wherein the hydrophilic fluid interface surface provides a water wetting contact angle that is less than a water wetting contact angle provided by the substrate.

Additional features and advantages of the disclosure will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by the practice of the disclosure. The objectives and other advantages of the disclosure will be realized and attained by the structure particularly pointed out in the written description and claims hereof as well as the appended drawings.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the disclosure as claimed.

Drawings

The accompanying drawings, which are included to provide a further understanding of the disclosure and are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and together with the description serve to explain the principles of the disclosure.

FIG. 1 depicts a schematic view of a typical assembled infusion set;

FIG. 2 depicts a schematic of the effect of a surface coating on the water wetting angle;

FIG. 3 is a perspective view of a control slide during an air bubble test according to aspects of the present disclosure;

FIG. 4 is a perspective view of a hydrophilic-coated slide during an air bubble test according to aspects of the present disclosure;

FIG. 5 is a perspective view of a hydrophobic-coated slide during an air bubble test according to aspects of the present disclosure;

FIG. 6 is a perspective view of a superhydrophobic-coated slide during an air bubble test according to aspects of the present disclosure;

FIG. 7 is a perspective view of a control plate during an air bubble test according to some aspects of the present disclosure;

FIG. 8 is a perspective view of a hydrophilic coated panel during an air bubble test according to aspects of the present disclosure;

FIG. 9 is a perspective view of the hydrophilic coated sheet of FIG. 7 over time during an air bubble test according to some aspects of the present disclosure;

FIG. 10 is a front cross-sectional view of a tube and infusion component adapter with a hydrophilic coating according to aspects of the present disclosure;

fig. 11 is a front view of a tube and infusion component adapter having a hydrophilic material according to aspects of the present disclosure.

Detailed Description

The detailed description set forth below describes various configurations of the subject technology and is not intended to represent the only configurations in which the subject technology may be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of the subject technology. Accordingly, as a non-limiting example, dimensions are provided with respect to certain aspects. It will be apparent, however, to one skilled in the art that the subject technology may be practiced without these specific details. In some instances, well-known structures and components are shown in block diagram form in order to avoid obscuring the concepts of the subject technology.

It is to be understood that this disclosure includes examples of the subject technology and does not limit the scope of the appended claims. Various aspects of the subject technology will now be disclosed in accordance with specific, but non-limiting, examples. The various embodiments described in this disclosure can be implemented in different ways and variations, and according to desired applications or implementations.

As shown in FIG. 1, a typical infusion set 30 has several different components, including a drip chamber 40, a check valve 50, a roller clamp 60, and a Y-fitting 70, all of which are connected together by tubing 20. A typical infusion set 30 may include additional infusion components (e.g., spring clips, filters) and may be formed from any combination of components and tubing 20. The addition of adapters, sensors and membrane technology has been used to capture air bubbles to minimize air bubbles and speed perfusion.

Fig. 2 shows the effect of a surface coating on the water wetting angle (e.g., contact angle). For example, the top portion of fig. 2 shows a water droplet 80 on a hydrophobic coating film 82. As shown, the water droplet 80 breaks away from the hydrophobic coating film 82 into a truncated oval shape that provides a contact angle 84 of greater than 90 degrees between an outer surface 86 of the water droplet 80 and the hydrophobic coating film 82. In contrast, as shown in the bottom portion of fig. 2, the water droplet 80 on the hydrophilic coating film 88 does not detach from the hydrophilic coating film 88, and thus has a hemispherical shape that provides a contact angle 84 of less than 90 degrees between the outer surface 86 of the water droplet 80 and the hydrophilic coating film 88.

According to aspects of the present disclosure, it is desirable to provide intravenous kits and intravenous components having hydrophilic properties that resist the adhesion of air bubbles to fluid interface surfaces. In one particular example, there is a clear need for a hazardous drug safety product to prevent exposure of the hazardous drug to health care workers using secondary line administration chemotherapy, where typical air relief solutions require increased priming time or additional handling of adapters, sensors, or membrane technology. By using the subject technology with hydrophilic properties, hazardous drug exposure is minimized, thereby reducing significant health risks (e.g., safety), increasing regulatory and guideline compliance (e.g., regulations), and reducing the time (e.g., workflow) required to prime a hazardous drug-filled secondary line.

In accordance with aspects of the present disclosure, the subject technology imparts hydrophilic surface properties to materials used for the fluid interface of infusion components and intravenous tubing. These hydrophilic surfaces provide lubricity better than hydrophobic surfaces, and the hydrophilic surfaces increase the wettability of the material, resulting in air bubbles not adhering to the surface (e.g., the tube wall). In addition, the lower coefficient of friction may allow air to slide across a surface faster due to the hydrophilic surface. Thus, these hydrophilic surface properties have bubble-stop features that allow air bubbles to slide off quickly while disappearing from the hydrophilic surface to prevent the air bubbles from adhering to the infusion component and the substrate of the intravenous tube (e.g., fluid interface surfaces), thereby improving fluid flow and providing bubble-free perfusion. These hydrophilic material-based infusion components and tubes provide improved ease of use for the user and eliminate the need for additional user training. Furthermore, the hydrophilicity of the fluid interface surface may provide anti-fouling properties for the infusion component and the iv tubing, which may provide for longer use of the infusion component/iv tubing/iv set before replacement is needed, as well as improve the efficiency of fluid delivery.

According to aspects of the present disclosure, the subject technology may be used in any drug delivery system that uses plastic components. The subject technology may be used for any component and/or critical component of a drug delivery system with a high risk of air bubble formation. For example, the tubing is one place where air often adheres, while the drip chamber is another area where air bubbles may be created during the perfusion and flow regulation or initial flow rate setting steps.

In some aspects of the present disclosure, the hydrophilic surface may be provided by coating a desired surface of the tube 20 or infusion component, such as the drip chamber 40. Here, the hydrophilic chemistry may be applied to a desired substrate. The substrate may comprise any suitable material, such as Thermoplastic Polyurethane (TPU), thermoplastic elastomer (TPE), Thermoplastic Polyolefin (TPO), flexible polyvinyl chloride (PVC), silicone, thermoplastic vulcanizate (TPV) (ethylene propylene diene monomer (EPDM) + polypropylene (PP)), thermoplastic styrene elastomer (TPS) (styrene-butadiene-styrene (SBS)/styrene-ethylene-butylene-styrene (SEBS)/styrene-isoprene-rubber (SIS)/styrene-ethylene-propylene-styrene (SEPS)) and mixtures thereof with polyolefins, and thermoplastic polyester elastomer (TPEE) (polyether ester) rubber, and the like. The hydrophilic nature of the surface may be provided by coating techniques and/or custom chemical compositions and synthesis by grafting methods.

The variables of the hydrophilic coating can be selected or controlled to achieve the desired hydrophilic properties. For example, these variables may include the type and chemical composition of the coating technique, the coating thickness, potential interactions with the processing or coating application technique, and the geometry that limits the application process.

In some aspects of the present disclosure, the hydrophilic surface may be provided by mixing hydrophilic chemicals or additives with the desired substrate. The substrate may comprise any suitable material, such as a flexible non-PVC (e.g., s-TPE/TPO/TPU or PVC material blends with hydrophilic additives). For example, polyvinylpyrrolidone (PVP), polyvinyl alcohol, chitosanPolysaccharides (CS), polyamides, polyethylene oxide (PEO), and polyethylene glycol (PEG) can be effective in reducing the contact angle 84 when added up to 10 wt%. Commercially available hydrophilic additives can be used, such as Irgasurf HL560 for PP and for polyolefin substrates

A polyetheramine. Guanidinium copolymers are another hydrophilic chemical that may be blended or coated. Additives of a hydrophilic nature may be mixed in the base polymer up to 20 wt% to provide different efficiencies.

The variables of the hydrophilic mixture can be selected or controlled to achieve the desired hydrophilic properties. For example, these variables may include the percentage of additive(s), the type of additive, the substrate chemistry, processing techniques, and the like.

Fig. 3-9 show control (e.g., uncoated) and experimental samples (e.g., coated) of a standard polycarbonate material 100 in the shape of a glass slide or plate. The samples were tested in the testing apparatus 120 and testing procedure to compare the air response on different surfaces of the sample plastic panel 100. The testing apparatus 120 includes a binding clip 130 attached to a dip rod 140 for a water bath 150, the binding clip 130 configured to hold slides/plates 100 or other test items. The water bath 150 is filled with water and an air source 160 injects air into the water bath 150. The sample slide/plate 100 is immersed in a water bath 150 directly above an air source 160. The results shown in fig. 3-9 show observations of the interaction of air bubbles with the fluid-facing surface of the slide/plate 100 within a wetted environment (as representative of fluid delivery).

As shown in fig. 3, a test of a control slide 102 (e.g., an uncoated polycarbonate slide) shows air bubbles adhering to the uncoated surface 103 of the uncoated slide 102. Furthermore, over time, air bubbles accumulate on the uncoated surface 103. The uncoated control slide 102 provided a contact angle 84 in the range of 65-75 degrees.

Fig. 4 shows a hydrophilic slide 104, the hydrophilic slide 104 being the same base polycarbonate as the control slide 102, but coated with a hydrophilic coating having a thickness of 100nm and providing a contact angle 84 in the range of 38-48 degrees. The hydrophilic slide 104 in fig. 4 is shown without air bubbles adhering to the coated surface 105 of the hydrophilic slide 104. Thus, any air bubbles that contact the coated surface 105 briefly adhere and detach, or do not adhere to the coated surface 105 but slide along the coated surface 105.

Fig. 5 shows a hydrophobic slide 106, the hydrophobic slide 106 being the same base polycarbonate as the control slide 102, but coated with a hydrophobic coating having a thickness of 500nm and providing a contact angle in the range of 90-94 degrees. Hydrophobic slide 106 in fig. 5 is shown with air bubbles adhering to the coated surface 107 of hydrophobic slide 106. Although the uncoated control slide 102 and the hydrophobic slide 106 have air bubbles sticking to the respective surfaces 103, 107, respectively, the size of the air bubbles on the hydrophobic slide 106 is significantly larger.

Fig. 6 shows a superhydrophobic slide 108, the superhydrophobic slide 108 being the same base polycarbonate as the control slide 102, but coated with a superhydrophobic coating having a thickness of about 1 μm and providing a contact angle greater than 150 degrees. The superhydrophobic slide 108 in fig. 6 is shown with air bubbles adhered to almost the entire coated surface 109 of the superhydrophobic slide 108. Furthermore, over time, air bubbles accumulate and collect over a large area of the coated surface 109.

As shown in fig. 7, testing of another control sample of uncoated PVC-grade plate 110 (representative of iv set pump tubing material) showed air bubbles adhering to the uncoated surface 111 of the uncoated plate 110. Here, over time, air bubbles again adhere, accumulate and collect to a larger area on the uncoated surface 111.

In fig. 8 and 9, a hydrophilic plate 112 is shown, the hydrophilic plate 112 being the same uncoated base PVC grade as the control sample 110 of fig. 7, but coated with a hydrophilic coating of varying thickness. The hydrophilic plate 112 in fig. 8 shows air bubbles contacting the coated surface 113 of the hydrophilic plate 112, while immediately in fig. 9, the air bubbles disappear from the coated surface 113. Therefore, the air bubbles contacting the coating surface 113 slide rapidly along the coating surface 113, or come off and disappear immediately after reaching the coating surface 113.

Fig. 10 illustrates an example of a hydrophilic tube and infusion component adapter 200 according to aspects of the present disclosure. Fitting 200 includes a tube 210 formed from any suitable material for infusion tubing, tube 210 having a hydrophilic coating 220 disposed on an interior (e.g., fluid interface) surface 230 of tube 210. The connector 200 also includes an infusion component fluid port 240, the fluid port 240 having a hydrophilic coating 220 disposed on an interior (e.g., fluid interface) surface 250 of the fluid port 240. Hydrophilic fitting 200 is configured to provide a pathway for fluid through tube 210 and fluid port 240 while minimizing or preventing air bubbles from adhering to or accumulating on interior surface 230 of tube 210 and interior surface 250 of fluid port 240.

Fig. 11 illustrates an example of a hydrophilic tube and infusion component adapter 300 in accordance with aspects of the present disclosure. Fitting 300 includes a tube 310 formed from a hydrophilic tubing material 320, tube 310 having an inner (e.g., fluid interface) surface 330. The hydrophilic tubing material 320 may be formed by mixing any suitable infusion tubing material (e.g., soft PVC) with one or more hydrophilic additives during formation (e.g., extrusion) of the tube 310. The connector 300 also includes an infusion component fluid port 340 formed from a hydrophilic infusion component material 360, the fluid port 340 having an interior (e.g., fluid interface) surface 350. The hydrophilic infusion member material 360 may be formed by mixing any suitable infusion member material (e.g., PVP) with one or more hydrophilic additives during formation (e.g., molding) of the fluid port 340. The hydrophilic fitting 300 is configured to provide a passage for fluid through the tube 310 and the fluid port 340 while minimizing or preventing air bubbles from adhering to or accumulating on the interior surface 330 of the tube 310 and the interior surface 350 of the fluid port 340.

According to aspects of the present disclosure, additional methods of creating hydrophilic surface properties of a fluid interface material are contemplated. For example, simple coating, coating with chemically reacted hydrophilic polymers, forming an impregnated polymer network, surface grafting of hydrophilic polymers, blending or complexing of hydrophilic polymers, impregnating polymeric materials with additives to modify surface properties to impart hydrophilicity, and forming Surface Hydrophilic Elastomeric Latex (SHEL) films on elastomeric, rubber-type materials.

In one or more embodiments of the present disclosure, a hydrophilic infusion tube includes a flexible tube configured to connect a first fluid port and a second fluid port, the flexible tube including a substrate adapted for fluid infusion and a hydrophilic fluid interface surface disposed on an inner surface of the flexible tube, wherein the hydrophilic fluid interface surface provides a water wetting contact angle that is less than a water wetting contact angle provided by the substrate.

In aspects of the present disclosure, the substrate includes one or more of Thermoplastic Polyurethane (TPU), thermoplastic elastomer (TPE), Thermoplastic Polyolefin (TPO), soft polyvinyl chloride (PVC), silicone, thermoplastic vulcanizate (TPV) (ethylene propylene diene monomer (EPDM) + polypropylene (PP)), thermoplastic styrene elastomer (TPS) (styrene-butadiene-styrene (SBS)/styrene-ethylene-butylene-styrene (SEBS)/styrene-isoprene-rubber (SIS)/styrene-ethylene-propylene-styrene (SEPS)) and mixtures thereof with polyolefins, and thermoplastic polyester elastomer (TPEE) (polyether ester) rubber. In aspects of the present disclosure, the hydrophilic fluid interface surface comprises a hydrophilic material coated on a substrate. In aspects of the present disclosure, the hydrophilic material includes a guanidinium copolymer. In aspects of the present disclosure, the hydrophilic material provides a lower coefficient of friction than the base material provides. In aspects of the present disclosure, the hydrophilic material provides a higher wettability of the material than that provided by the substrate.

In aspects of the present disclosure, the hydrophilic fluid interface surface comprises a hydrophilic material grafted onto a substrate. In aspects of the present disclosure, the hydrophilic fluid interface surface comprises a mixture of a substrate and a hydrophilic additive. In aspects of the present disclosure, the hydrophilic additive includes one or more hydrophilic additives of polyvinylpyrrolidone (PVP), polyvinyl alcohol, Chitosan (CS), polyamide, polyethylene oxide (PEO), polyethylene glycol (PEG), and polyetheramine. In aspects of the present disclosure, the hydrophilic additive comprises a guanidinium copolymer. In aspects of the present disclosure, the hydrophilic additive comprises up to 10% by weight of the combination of the substrate and the hydrophilic additive. In aspects of the present disclosure, the hydrophilic additive comprises up to 20% by weight of the combination of the substrate and the hydrophilic additive.

In one or more embodiments of the present disclosure, a hydrophilic infusion component includes a housing including a first fluid port; a second fluid port; a substrate suitable for fluid infusion; and a fluid path disposed between the first fluid port and the second fluid port. The hydrophilic infusion component also includes a hydrophilic fluid interface surface disposed on an inner surface of the fluid pathway, wherein the hydrophilic fluid interface surface provides a water wetting contact angle that is less than a water wetting contact angle provided by the substrate.

In aspects of the present disclosure, the substrate includes one or more of Thermoplastic Polyurethane (TPU), thermoplastic elastomer (TPE), Thermoplastic Polyolefin (TPO), soft polyvinyl chloride (PVC), silicone, thermoplastic vulcanizate (TPV) (ethylene propylene diene monomer (EPDM) + polypropylene (PP)), thermoplastic styrene elastomer (TPS) (styrene-butadiene-styrene (SBS)/styrene-ethylene-butylene-styrene (SEBS)/styrene-isoprene-rubber (SIS)/styrene-ethylene-propylene-styrene (SEPS)) and mixtures thereof with polyolefins, and thermoplastic polyester elastomer (TPEE) (polyether ester) rubber.

In aspects of the present disclosure, the hydrophilic fluid interface surface comprises a hydrophilic material coated on a substrate. In aspects of the present disclosure, the hydrophilic fluid interface surface comprises a hydrophilic material grafted onto a substrate. In aspects of the present disclosure, the hydrophilic fluid interface surface comprises a mixture of a substrate and a hydrophilic additive. In aspects of the present disclosure, the hydrophilic additive includes one or more hydrophilic additives of polyvinylpyrrolidone (PVP), polyvinyl alcohol, Chitosan (CS), polyamide, polyethylene oxide (PEO), polyethylene glycol (PEG), polyetheramine, and guanidine salt copolymer.

In one or more embodiments of the present disclosure, an infusion set includes an infusion component and a hydrophilic infusion tube. The hydrophilic infusion tube comprises a flexible tube configured to connect the fluid port of the infusion component to a different fluid port, the flexible tube comprising a substrate suitable for fluid infusion; and a hydrophilic fluid interface surface disposed on the inner surface of the flexible tube, wherein the hydrophilic fluid interface surface provides a water wetting contact angle that is less than a water wetting contact angle provided by the substrate, and wherein the flexible tube is configured to provide a fluid channel free of air bubble accumulation on the inner surface of the flexible tube.

In an aspect of the present disclosure, the infusion part is a hydrophilic infusion part comprising: a housing including a first fluid port; a second fluid port; a substrate suitable for fluid infusion; and a fluid path disposed between the first fluid port and the second fluid port. The hydrophilic infusion component further comprises a hydrophilic fluid interface surface disposed on an inner surface of the fluid pathway, wherein the hydrophilic fluid interface surface provides a water wetting contact angle that is less than a water wetting contact angle provided by the substrate, and wherein the fluid pathway is configured to provide a fluid channel free of air bubble accumulation on the inner surface of the fluid pathway.

It should be understood that any particular order or hierarchy of blocks in the methods of the disclosed processes is an illustration of example methods. Based upon design or implementation preferences, it is understood that the specific order or hierarchy of blocks in the processes may be rearranged or that all illustrated blocks may be performed. In some implementations, any of the blocks may be executed concurrently.

The present disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. The present disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects.

Unless specifically stated otherwise, reference to an element in the singular is not intended to mean "one and only one" but rather "one or more. The term "some" means one or more unless specifically stated otherwise. A positive pronoun (e.g., his) includes negative and neutral pronouns (e.g., her and its), and vice versa. Headings and sub-headings, if any, are used for convenience only and do not limit the invention.

The word "exemplary" is used herein to mean "serving as an example or illustration. Any aspect or design described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other aspects or designs. In one aspect, various alternative configurations and operations described herein may be considered at least equivalent.

As used herein, the phrase "at least one of," preceding a series of items, separates any items from the term "or," modifies the list as a whole rather than each item of the list. The phrase "at least one" does not require the selection of at least one item; rather, the phrase allows the meaning of at least one of any one item, and/or at least one of any combination of items, and/or at least one of each item. For example, the phrase "A, B or at least one of C" may refer to: only a, only B, or only C; or A, B, C in any combination.

Phrases such as "an aspect" do not imply that such aspect is essential to the subject technology or that such aspect applies to all configurations of the subject technology. The disclosure relating to an aspect may apply to all configurations or one or more configurations. An aspect may provide one or more examples. A phrase such as an aspect may refer to one or more aspects and vice versa. Phrases such as "an embodiment" do not imply that such embodiment is essential to the subject technology or that such embodiment applies to all configurations of the subject technology. The disclosure relating to an embodiment may apply to all embodiments, or one or more embodiments. An embodiment may provide one or more examples. The phrase of such an embodiment may refer to one or more embodiments, and vice versa. A phrase such as a "configuration" does not imply that such configuration is essential to the subject technology or that such configuration applies to all configurations of the subject technology. The disclosure relating to a configuration may apply to all configurations or one or more configurations. One configuration may provide one or more examples. The phrase such a configuration may refer to one or more configurations and vice versa.

In one aspect, unless otherwise specified, all measurements, values, ratings, positions, sizes, dimensions, and other specifications set forth in this specification, including the following claims, are approximate, and not precise. In one aspect, they are intended to have a scope reasonably consistent with the functionality to which they pertain and the routine practice in the field to which they pertain.

It should be understood that the specific order or hierarchy of steps, operations, or processes disclosed is an illustration of exemplary approaches. Based upon design preferences, it is understood that the specific order or hierarchy of steps, operations, or processes may be rearranged. Some steps, operations, or processes may be performed concurrently. Some or all of the steps, operations or processes may be performed automatically, without user intervention. The accompanying method claims, if any, present elements of the various steps, operations, or processes in a sample order, and are not meant to be limited to the specific order or hierarchy presented.

All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims. No claim element should be construed in accordance with the provisions of 35u.s.c. § 112(f), unless the element is explicitly recited using the phrase "means for … …" (or in the case of a method claim, the element is stated using the phrase "step for … …". Furthermore, to the extent that the terms "includes," "has," and the like are used, such terms are intended to be inclusive in a manner similar to the term "comprising" as "comprising" is interpreted when employed as a transitional word in a claim.

The title, background, summary, brief description of the drawings, and abstract of the disclosure are hereby incorporated into the disclosure and are provided as illustrative examples of the disclosure, not as limiting descriptions. The present invention is submitted with the understanding that it will not be used to limit the scope or meaning of the claims. Furthermore, as can be seen in the detailed description, this description provides illustrative examples, and various features are grouped together in various embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed configuration or operation. The following claims are hereby incorporated into the detailed description, with each claim standing on its own as a separately claimed subject matter.

The claims are not intended to be limited to the aspects described herein, but is to be accorded the full scope consistent with the language of the claims, and including all legal equivalents. Notwithstanding, none of the claims are intended to embrace subject matter that fails to meet the requirements of 35u.s.c. § 101, 102 or 103, nor should they be construed in this manner.

Claims (20)

1. A hydrophilic infusion tube comprising:

a flexible tube configured to connect a first fluid port and a second fluid port, the flexible tube comprising a substrate suitable for fluid infusion; and

a hydrophilic fluid interface surface disposed on an inner surface of the flexible tube,

wherein the hydrophilic fluid interface surface provides a water wetting contact angle that is less than a water wetting contact angle provided by the substrate.

2. The hydrophilic infusion tube of claim 1, wherein the substrate comprises one or more of Thermoplastic Polyurethane (TPU), thermoplastic elastomer (TPE), Thermoplastic Polyolefin (TPO), soft polyvinyl chloride (PVC), silicone, thermoplastic vulcanizate (TPV) (ethylene propylene diene monomer (EPDM) + polypropylene (PP)), thermoplastic styrene elastomer (TPS) (styrene-butadiene-styrene (SBS)/styrene-ethylene-butylene-styrene (SEBS)/styrene-isoprene-rubber (SIS)/styrene-ethylene-propylene-styrene (SEPS)) and mixtures thereof with polyolefins, and thermoplastic polyester elastomer (TPEE) (polyetherester) rubber.

3. The hydrophilic infusion tube of claim 1, wherein the hydrophilic fluid interface surface comprises a hydrophilic material coated on the substrate.

4. The hydrophilic infusion tube of claim 3, wherein the hydrophilic material comprises a guanidinium copolymer.

5. The hydrophilic infusion tube of claim 3, wherein the hydrophilic material provides a coefficient of friction that is lower than a coefficient of friction provided by the base material.

6. The hydrophilic infusion tube of claim 3, wherein the hydrophilic material provides a material wettability that is higher than a material wettability provided by the substrate.

7. The hydrophilic infusion tube of claim 1, wherein the hydrophilic fluid interface surface comprises a hydrophilic material grafted onto the substrate.

8. The hydrophilic infusion tube of claim 1, wherein the hydrophilic fluid interface surface comprises a mixture of the substrate and a hydrophilic additive.

9. The hydrophilic infusion tube of claim 8, wherein the hydrophilic additive comprises one or more of polyvinylpyrrolidone (PVP), polyvinyl alcohol, Chitosan (CS), polyamides, polyethylene oxide (PEO), polyethylene glycol (PEG), and polyetheramines.

10. The hydrophilic infusion tube of claim 8, wherein the hydrophilic additive comprises a guanidinium copolymer.

11. The hydrophilic infusion tube of claim 8, wherein the hydrophilic additive comprises up to 10 percent by weight of the substrate and hydrophilic additive combination.

12. The hydrophilic infusion tube of claim 8, wherein the hydrophilic additive comprises at most 20 percent by weight of the substrate and hydrophilic additive combined.

13. A hydrophilic infusion component comprising:

a housing, the housing comprising:

a first fluid port;

a second fluid port;

a substrate suitable for fluid infusion; and

a fluid path disposed between the first fluid port and the second fluid port; and

a hydrophilic fluid interface surface disposed on an inner surface of the fluid path,

wherein the hydrophilic fluid interface surface provides a water wetting contact angle that is less than a water wetting contact angle provided by the substrate.

14. A hydrophilic infusion part according to claim 13, wherein the substrate comprises one or more of Thermoplastic Polyurethane (TPU), thermoplastic elastomer (TPE), Thermoplastic Polyolefin (TPO), soft polyvinyl chloride (PVC), silicone, thermoplastic vulcanizate (TPV) (ethylene propylene diene monomer (EPDM) + polypropylene (PP)), thermoplastic styrene elastomer (TPS) (styrene-butadiene-styrene (SBS)/styrene-ethylene-butylene-styrene (SEBS)/styrene-isoprene-rubber (SIS)/styrene-ethylene-propylene-styrene (SEPS)) and mixtures thereof with polyolefins, and thermoplastic polyester elastomer (TPEE) (polyetherester) rubber.

15. The hydrophilic infusion component of claim 13, wherein the hydrophilic fluid interface surface comprises a hydrophilic material coated on the substrate.

16. The hydrophilic infusion component of claim 13, wherein the hydrophilic fluid interface surface comprises a hydrophilic material grafted onto the substrate.

17. The hydrophilic infusion component of claim 13, wherein the hydrophilic fluid interface surface comprises a mixture of the substrate and a hydrophilic additive.

18. The hydrophilic infusion component of claim 17 wherein the hydrophilic additive comprises one or more of polyvinylpyrrolidone (PVP), polyvinyl alcohol, Chitosan (CS), polyamides, polyethylene oxide (PEO), polyethylene glycol (PEG), polyetheramines, and guanidinium copolymers.

19. An infusion set comprising:

an infusion component; and

a hydrophilic infusion tube, the hydrophilic infusion tube comprising:

a flexible tube configured to connect the fluid port of the infusion component to a different fluid port, the flexible tube comprising a substrate suitable for fluid infusion; and

a hydrophilic fluid interface surface disposed on an inner surface of the flexible tube,

wherein the hydrophilic fluid interface surface provides a water wetting contact angle that is less than a water wetting contact angle provided by the substrate,

wherein the flexible tube is configured to provide a fluid channel without accumulation of air bubbles on an inner surface of the flexible tube.

20. An infusion set in accordance with claim 19, wherein the infusion member is a hydrophilic infusion member comprising:

a housing, the housing comprising:

a first fluid port;

a second fluid port;

a substrate suitable for fluid infusion; and

a fluid path disposed between the first fluid port and the second fluid port;

and

a hydrophilic fluid interface surface disposed on an inner surface of the fluid path,

wherein the hydrophilic fluid interface surface provides a water wetting contact angle that is less than a water wetting contact angle provided by the substrate,

wherein the fluid path is configured to provide a fluid channel without accumulation of air bubbles on an inner surface of the fluid path.

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